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Protocol For Use of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma

18 Years
Open (Enrolling)
Carcinoma, Hepatocellular, Liver Cancer

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Trial Information

Protocol For Use of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma

TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that
has been used to treat liver tumors. When Y-90 is put into microscopic glass beads, called
microspheres, it can be injected directly into the liver by vein. This allows a large dose
of radiation to be delivered directly to the tumor, which lowers the risk of experiencing
toxic radiation side effects from the radiation to in other parts of the body, or to healthy
liver tissue. The radiation from TheraSphere treatment stays in the body and begins to lose
its effect within 12 days, due to physical decay (please refer to the package insert for
more information for more information regarding this). The glass microspheres will stay in
the body from that point on, but should not cause any health problems.

All visits and procedures related to the TheraSphere treatment will be performed on an
outpatient basis. About 2 weeks before the treatment begins, a small tube (catheter) will
be inserted into a vein that goes to the liver, usually in the thigh.

TheraSphere Treatment:

TheraSphere (microspheres filled with Y-90 as described above) will be injected into the
tumor in the liver through a catheter that you have already had placed into an artery during
an earlier procedure.

You will receive at least 1 TheraSphere injection while you are receiving the treatment. If
the doctor thinks it is needed, you will have a second injection about 1 month later. The
number of TheraSphere injections you will receive will depend on the size and location of
the tumors. The injection should take about 5 minutes to complete each time.

After receiving the TheraSphere injection, you will stay at the hospital for several hours
so that the staff can check you for possible side effects. If you experience any serious
problems or complications after receiving the injection, you may be admitted to the hospital
for observation and possible additional treatment.

Length of Treatment:

You will continue to receive the HUD treatment indefinitely.

TheraSphere is a humanitarian use device that is approved by the FDA for the treatment of
rare disorders affecting less than 4,000 people in the U.S. each year.

All of the tests and procedures that will be performed as part of this treatment protocol
are considered to be standard care, including the TheraSphere.

Up to 200 patients will receive the treatment. All will be enrolled at M.D. Anderson.

Inclusion Criteria:

1. Diagnosis of unresectable intrahepatic HCC. The histopathology confirmation criterion
may be waived in patients with a radiographically identifiable liver mass, known
laboratory or clinical risk factors for cancer or elevated tumor markers such as
alphafetoprotein (AFP)^21 and clinical findings. Guidelines from the American
Association for the Study of Liver Diseases (AASLD) and the European Association for
the Study of the Liver (EASL) describe in detail the approach and algorithm for
diagnosing HCC.

2. Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 1

3. Life expectancy >/= 3 months

4. > 4 weeks since prior radiation, surgery or chemotherapy

5. Able to comprehend and provide written informed consent in accordance with
institutional and federal guidelines.

Exclusion Criteria:

1. Any pre-treatment laboratory findings within 15 days of treatment demonstrating liver
dysfunction: • AST (Serum Glutamic-Oxalacetic Transaminase - SGOT) or ALT (Serum
Glutamic-Pyruvic Transaminase - SGPT) > 5 times Upper Normal Limit (UNL) • Serum
bilirubin > 2.0 mg/dl (unless segmental infusion is planned)

2. Any contraindications to angiography and hepatic artery catheterization such as:
History of severe allergy or intolerance to any contrast media, narcotics, sedatives,
or atropine that cannot be corrected or premedicated; Bleeding diathesis, not
correctable by usual forms of therapy; Severe peripheral vascular disease that would
preclude catheterization.

3. Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of
radiation to the lungs in a single treatment

4. Clinical evidence of pulmonary insufficiency

5. Evidence of any detectable Technetium-99 Macroaggregated Albumin (Tc-99m MAA) flow to
the stomach or duodenum, after application of established angiographic techniques to
stop or mitigate such flow.

6. Complete occlusion of the main portal vein.

7. Significant extrahepatic disease representing an imminent life-threatening outcome

8. Active uncontrolled infection.

9. Significant underlying medical or psychiatric illness.

10. Co-morbid disease of condition that would preclude safe delivery of TheraSphere
treatment or, in the judgment of the physician, place the patient at undue risk

11. Pregnancy

12. Tumor type demonstrated on imaging to be infiltrative, tumor volume > 70% of the
target liver volume, or tumor nodules too numerous to count, or tumor volume > 50%
combined with an albumin < 3 g/dL, or complete occlusion of the main portal vein.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival Associated With TheraSphere Treatment

Outcome Time Frame:

3-6 weeks post treatment

Safety Issue:


Principal Investigator

Armeen Mahvash, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2010

Completion Date:

Related Keywords:

  • Carcinoma, Hepatocellular
  • Liver Cancer
  • Hepatocellular carcinoma (HCC) of the liver
  • Hepatocellular cancer
  • Hepatocellular carcinoma
  • Liver cancer
  • HCC
  • Humanitarian Device Exemption
  • Liver Diseases
  • (HDE)
  • Radioactive
  • TheraSphere
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



UT MD Anderson Cancer CenterHouston, Texas  77030